Clinical Trial Regulation Information Day for CEE Countries

Are Central and Eastern European Union member states ready to implement the new EU Clinical Trial Regulation (536/2014)? This information day provides a platform for discussion about the status of the implementation and further compliance with the new Regulation, as well as the associated legislation in the region.

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Session 3: Procedure for Initial Authorization and Substantial Modifications

Session Chair(s)

Vladimir Vujovic, MPharm

Director, Clinical Trials Regulatory

IQVIA, Serbia

Procedure for Initial Authorization and Substantial Modifications

Speaker(s)

Submission of application process

Stefan Strasser, MD

AGES, Austria

Head of Clinical Trials, Institute Surveillance

Reference Safety Information (RSI)

Massimiliano Sarra, PhD, MPH

Italian Medicine Agency (AIFA), Italy

Permanent official and CTFG Secretary

New Process for Clinical Trial Registration and EU Clinical Trial Number Application

Camelia Mihaescu

European Medicines Agency, Netherlands

GCP, GLP and PhV Inspections